Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) and its Japanese partner Eisai Co Ltd (TYO:4523) announced on Tuesday that the Biologics License Application covering a subcutaneous formulation of Leqembi (lecanemab) for early Alzheimer's disease has been accepted by China's National Medical Products Administration.

This application relates to a subcutaneous autoinjector that, if approved, would allow at-home, once-weekly dosing from treatment initiation, as an alternative to intravenous administration in hospital every two weeks.

The proposed formulation is designed to reduce healthcare resource use associated with infusions and streamline the Alzheimer's treatment pathway. Eisai has submitted similar applications for subcutaneous initiation dosing to regulators in the United States and Japan, while subcutaneous maintenance dosing has already been approved in the United States.

Eisai estimates that China had approximately 17 million patients with mild cognitive impairment or mild dementia due to Alzheimer's disease in 2024.

Leqembi was developed through a long-standing collaboration between BioArctic and Eisai, with Eisai responsible for development and commercialisation and BioArctic retaining commercialisation rights in the Nordic region.